Safety and Efficacy Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis

NCT03005964 | Completed Phase 2

• 1 other identifier: AD-AM001-001A
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the treatment of plaque psoriasis

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Investigator's Global Assessment of Disease Severity (IGA)

  An assessment of disease severity will be performed at each study visit

  12 weeks

Secondary Outcomes (4)

• Target Lesion Psoriasis Area Severity Index (PASI)

  12 weeks

• Body Surface Area (BSA)

  12 weeks

• Target Lesion Area

  12 weeks

• Dermatology Life Quality Index (DLQI)

  12 weeks

Study Arms (2)

AM001 Cream, 7.5%

EXPERIMENTAL

A white to off-white Cream free from any foreign particles

Drug: AM001 Cream, 7.5%

Vehicle Cream

PLACEBO COMPARATOR

A white to off-white Cream free from any foreign particles.

Drug: Vehicle Cream

Interventions

AM001 Cream, 7.5% DRUG

Active Cream

Also known as: Potassium Dobesilate

AM001 Cream, 7.5%

Vehicle Cream DRUG

Placebo

Also known as: Placebo Cream

Vehicle Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must provide written informed consent.
• Subjects must be male or female, at least 18 years of age.
• Subjects with a definite diagnosis of plaque psoriasis that is clinically active (for at least 3 months), involving at least 10% and up to 20% of the body surface area (not including the head \[ scalp, face\], hands, feet, and intertriginous areas).
• Subjects with an Investigator's Global Assessment (IGA) of disease severity of at least moderate severity (score ≥ 3) as an overall assessment.
• Subjects with a target lesion which has the following characteristics:
• located on the extremities (i.e., arms or legs ) and has an area of ≥25 cm2;
• has a minimum plaque erythema of at least moderate severity (PASI grade ≥ 3);
• has a minimum plaque scaling severity of at least moderate severity (PASI grade ≥ 3);
• has a minimum plaque elevation of at least moderate severity (PASI grade ≥ 3);
• If females of childbearing potential, the subject must have a negative urine pregnancy test, and must have been using an acceptable form of birth control for at least two months prior to Visit 1/Screening and are willing to continue birth control throughout the study.
• Subjects must be willing and able to understand and comply with the requirements of the study, apply the assigned investigational product as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
• Subjects must be in good health, as confirmed by medical history and physical exam, and free from any clinically significant disease/condition, other than plaque psoriasis, that might interfere with the study evaluations.
• Subjects must be willing to limit sun exposure overall. Subjects are prohibited from sunbathing or intentional tanning or intense sun exposure including the use of tanning booths/lights or other artificial UV light sources throughout the study.

You may not qualify if:

• Female subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
• Subjects who have a current diagnosis of guttate, pustular, inverse, exfoliative, or erythrodermic psoriasis.
• Subjects who have a history of psoriasis unresponsive to topical treatments.
• Subjects who have a history of a disorder that may interfere with the evaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, cutaneous lymphoma, etc.).
• Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
• Subjects with unstable medical disorders, life-threatening disease, or current malignancies.
• Subjects with clinically significant ECG or laboratory abnormalities at Visit 1/Screening (as determined by the Principal Investigator or designee).
• Subjects who are immunosuppressed.
• Subjects who have a history of allergy or a known hypersensitivity to any component of the investigational product.
• Subjects who have been treated with any systemic steroids within the 4 weeks prior to the study entry (intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study, and intra-articular steroid injections are permissible).
• Subjects who have been treated with systemic or photo antipsoriatic therapies/drugs within 4 weeks prior to study entry including methotrexate, cyclosporine, acitretin and other oral retinoids, broadband or narrowband UVB, PUVA, home or professional tanning lights or other nonprescription UV light sources, photodynamic therapy (PDT), lasers, mycophenalate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-mercaptopurine (6-MP), or etanercept.
• Subjects treated with any other biologic agent not listed here for psoriasis or psoriatic arthritis within 12 weeks.
• Subjects who have been treated with any topical anti-psoriatic (e.g., salicylic acid, anthralin, tar, etc.,) any topical corticosteroid medications, topical retinoids (e.g., tazarotene, tretinoin), topical Vitamin D analogs (e.g., calcipotriene), topical immunosuppressants (e.g., tacrolimus, pimecrolimus) within 2 weeks prior to study entry.
• Subjects who have been treated with lithium, antimalarial agents, or quinidine within the 4 weeks prior to study entry.
• Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken any immunosuppressant medication within 3 months prior to study entry.

Sponsors & Collaborators

• AmDerma: lead
• International Dermatology Research, Inc.: collaborator

Study Sites (2)

Instituto Dermatogical y Cirugia de Piel

San Cristóbal, Dominican Republic

Location

Instituto Dermatologico Blanco Falette, MD

Santo Domingo, Dominican Republic

Location

MeSH Terms

Interventions

potassium dobesilate

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: December 1, 2016
• Primary Completion: August 15, 2017
• Study Completion: September 4, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DO (2)